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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Vet
Pets & Animals/Pet Medications

Ofloxacin Ophthalmic Solution Recalled for High Impurity Levels

Agency Publication Date: September 6, 2022
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Summary

Akorn, Inc. has voluntarily recalled 37,582 bottles of Ofloxacin Ophthalmic Solution, USP 0.3%, a prescription antibiotic eye drop used to treat bacterial eye infections in animals. The recall was initiated because routine testing discovered that a specific impurity (N-Oxide) exceeded approved limits after 23 months of storage. No incidents or injuries have been reported to date, but consumers should stop using the affected bottles immediately. If your pet has been treated with this medication and shows signs of irritation, contact your veterinarian.

Risk

The eye drops contain levels of an impurity that exceed the allowed specification, which could potentially reduce the effectiveness of the medication or cause unexpected irritation to the animal's eye.

What You Should Do

  1. Check your bottle of Ofloxacin Ophthalmic Solution, USP 0.3% (5 mL dropper bottle) for Lot 0J79A and NDC 13985-602-05.
  2. If you have animal health concerns, contact your veterinarian. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer or supplier for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: If you have animal health concerns, contact your veterinarian. Return any unused product to the place of purchase for a refund, or contact the manufacturer or supplier for further instructions
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away.

Affected Products

Product: Ofloxacin Ophthalmic Solution, USP 0.3% (5 mL)by Akorn, Inc.
Variants: Sterile, Rx Only
Lot Numbers:
0J79A
NDC:
13985-602-05

Manufactured by Akorn, Inc. in Lake Forest, IL; Distributed by MWI in Boise, ID.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90821
Status: Resolved
Manufacturer: Akorn, Inc.
Sold By: MWI; Pharmacies
Manufactured In: United States
Units Affected: 37,582 bottles
Distributed To: Nationwide
Agency Last Updated: September 21, 2022

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response